A Double-blind, Oral, Multiple-dose, Parallel, Randomized Study to Evaluate Efficacy and Safety of Endoxifen in Bipolar I Disorder Patients with Acute Mania Episodes with or Without Mixed Features

Bipolar disorder (BPD) is a chronic debilitating illness characterized by drastic swings in mood, energy and functional ability that affects the adult population. Endoxifen is an active metabolite of the marketed drug Tamoxifen and the present study aims to evaluate the efficacy and safety of 8 mg endoxifen in the Bipolar I disorder patient population compared to a placebo arm. Endoxifen will be compared to a placebo to demonstrate that the test product is active and to establish that the study is sufficiently sensitive to detect differences between the investigational products. Thus, Endoxifen will be compared to placebo to demonstrate that the test product is safe and active.

Start Date19 Mar 2024

Sponsor / Collaborator

Jina Pharmaceuticals, Inc.

[+1]

NCT06075953

/ RecruitingPhase 2

DCIS: RECAST Trial -Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: a Breast Cancer Prevention Pilot Study

The goal of this trial is to see if active surveillance monitoring and hormonal therapy in patients diagnosed with ductal cell carcinoma in situ (DCIS), an early stage of breast cancer, can be an effective management of the disease.
Participants will be asked to receive control hormonal therapy or an investigational hormonal therapy treatment. Participants will be asked to return for evaluation with MRI at three months and six months. Depending on the evaluation participants will have the option to continue on the treatment. If the evaluation suggests surgery is recommended, the participant will discontinue the study treatment and will undergo surgery. In addition to the treatment and MRI evaluation, participants will be asked to provide blood sample to understand their immune status, provide saliva sample for genetic testing, provide the study with a portion of the tissue or slides generated from tissue removed during surgery performed as part of their standard of care.

Start Date14 Feb 2024

Sponsor / Collaborator

Quantumleap Healthcare Collaborative

NCT05607004

/ RecruitingPhase 2

A Randomized Phase 2 Non-inferiority Trial of (Z)-Endoxifen + Goserelin Versus Exemestane + Goserelin as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Ki-67>10% Breast Cancer and a Single Arm Phase 2 Study of (Z)-Endoxifen as Neoadjuvant Treatment for Premenopausal Women With ER+, HER2-, Ki-67 ≤ 10% Breast Cancer

This open-label research study is studying (Z)-endoxifen as a possible treatment for pre-menopausal women with ER+/HER2- breast cancer. (Z)-endoxifen belongs to a group of drugs called selective estrogen receptor modulators or "SERM", which help block estrogen from attaching to cancer cells. This study has two parts: a pharmacokinetic part and a treatment part.
The PK part (how the body processes the drug) will enroll about 18 participants. All participants will take (Z)-endoxifen capsules daily. Twelve participants will be randomly assigned (50/50 chance) to take (Z)-endoxifen alone or (Z)-endoxifen with a monthly injection of goserelin a drug that temporarily stops the ovaries from making estrogen. This part will help determine the best dose of (Z)-endoxifen by measuring the drug levels in the blood and how long the body takes to remove it.
The treatment part has two parts:
* Part 2a will enroll 162 participants whose tumors have a high level of cell proliferation as indicated by the presence of a biomarker called Ki-67 (greater than 10%). Participants will be randomly assigned to one of two groups (50/50 chance):
1. a group receiving (Z)-endoxifen daily with a monthly injection of goserelin
2. a group receiving the current standard treatment of exemestane (an aromatase inhibitor that lowers estrogen) with a monthly injection of goserelin.
* The Part 2b will enroll about 30 participants whose tumors have low Ki-67 levels (10% or less). These participants will take daily (Z)-endoxifen alone without goserelin.
A key goal of the study is to see if (Z)-endoxifen can slow down or stop tumor growth as measured by a reduction in Ki-67 levels. Tumor tissue samples will be taken by breast biopsy after about 4 weeks of treatment to check levels of this biomarker. If the tumor shows signs of response, participants can continue treatment for up to 24 weeks or until they have surgery.
Study participation is up to 6 months (24 weeks of treatment) followed by surgery and a one-month follow up visit.

Start Date14 Feb 2023

Sponsor / Collaborator

Atossa Therapeutics, Inc.

[+1]

100 Clinical Results associated with Endoxifen

100 Translational Medicine associated with Endoxifen

100 Patents (Medical) associated with Endoxifen

612

Literatures (Medical) associated with Endoxifen

01 May 2025·BREAST CANCER RESEARCH AND TREATMENT

The impact of coadministration of venlafaxine, citalopram or gabapentin on the metabolic activation of tamoxifen

Article

Author: Goetz, Matthew P ; Stearns, Vered ; Ames, Matthew M ; Denduluri, Neelima ; Henry, N Lynn ; Suman, Vera J ; Ingle, James N ; Loprinzi, Charles L ; Weinshilboum, Richard M ; Black, John L ; Kosel, Matthew L ; Irvin, William ; Sideras, Kostantinos ; Leon Ferre, Roberto A ; Safgren, Stephanie L ; Reid, Joel M

PURPOSE:

Tamoxifen undergoes metabolic activation by cytochrome P450 (CYP) enzymes to metabolites with more potent anti-estrogenic effects. Numerous studies demonstrate decreased tamoxifen efficacy associated with reduced CYP2D6 activity or lower Z-endoxifen concentrations. Women taking tamoxifen frequently experience vasomotor symptoms (VMS) that may require medical treatment. Many medications used for VMS or depression are CYP substrates that may reduce Z-endoxifen concentrations. While the drug-drug interactions (DDI) from potent CYP2D6 inhibitors (CYPi) on tamoxifen metabolism has been studied, the impact of less potent CYPi including drugs used to treat VMS remains largely unknown.

METHODS:

We performed a prospective trial to evaluate the impact of gabapentin or non-potent CYPi (venlafaxine citalopram) on plasma concentrations of tamoxifen and its metabolites (Z-endoxifen, N-desmethyl-tamoxifen (NDMT) and 4-hydroxy-tamoxifen (4HT).

RESULTS:

Patients enrolled were intermediate to extensive metabolizers by CYP2D6 genotyping. While tamoxifen and NDMT plasma concentrations were not significantly altered, the percent decrease in plasma Z-endoxifen concentration was statistically significant with the addition of venlafaxine (n = 22) or citalopram (n = 18) (median - 14.7 and - 14.4%, respectively) but not with gabapentin (n = 14) (median - 2.3%). A reduction in Z-endoxifen concentrations below the 5.9 ng/ml threshold associated with tamoxifen efficacy was observed in 12% of patients.

CONCLUSION:

The addition of venlafaxine and citalopram but not gabapentin during tamoxifen treatment decreases plasma Z-endoxifen concentrations. SSRIs/SNRIs affecting tamoxifen biotransformation pathways, but with less potent CYPi potential, should be used cautiously in tamoxifen-treated patients and non-CYP inhibiting medications considered when possible.

01 Apr 2025·Asian Journal of Psychiatry

ERR on the side of caution with endoxifen? – A case series

Letter

Author: Kakkan, Sushil ; Raj, Zoheb ; Nair, Pranav V ; Velayudhan, Rajmohan ; Babu, Bindhya

01 Apr 2025·JNCI-Journal of the National Cancer Institute

Influence of endoxifen on mammographic density: results from the KARISMA-Tam trial

Article

Author: Eliasson, Erik ; Bergqvist, Jenny ; Hammarström, Mattias ; Eriksson, Mikael ; Borgquist, Signe ; Tapia, José ; Lundholm, Cecilia ; Gabrielson, Marike ; Hall, Per ; Crippa, Alessio ; Bäcklund, Magnus ; Czene, Kamila ; Wengström, Yvonne

Abstract:

Background:

Monitoring metabolites of tamoxifen, such as endoxifen, has been suggested as a strategy to ascertain therapeutic effect of tamoxifen therapy, but clinical guidelines are missing. Herein, we aim to investigate the outcome of endoxifen concentrations of low-dose tamoxifen, using change in mammographic breast density as a proxy for therapy response.

Methods:

In the randomized KARISMA-Tam (Karolinska Mammography project for risk prediction of breast cancer -Intervention Study with Tamoxifen) trial, including 5 doses of tamoxifen, measurements of plasma endoxifen concentrations, determination of CYP2D6 metabolizer status, and mammographic breast density change over the trial period were carried out. Association between endoxifen concentrations and relative mammographic breast density change after 6 months treatment was analyzed using linear regression in a spline model.

Results:

A total of 824 women (335 premenopausal, 489 postmenopausal) were included. In analyses of premenopausal women, a spline model described a mammographic breast density decrease, equivalent to the mean (−18.5%) seen in women exposed to 20 mg tamoxifen, at endoxifen concentrations of 2-3 ng/mL. The mammographic breast density decrease reached a nadir at endoxifen levels of 3 ng/mL and did not decrease further at higher endoxifen concentrations. Most intermediate and normal tamoxifen metabolizers (about 90% of all participants) reached an endoxifen concentration of more than 2 ng/mL at tamoxifen doses of 5 and 10 mg. No mammographic breast density decrease was seen in the postmenopausal group.

Conclusions:

We have identified a possible window of effect on mammographic breast density at endoxifen concentrations of 2-3 ng/mL in premenopausal women, which corresponds to the doses of 5 and 10 mg tamoxifen. Because mammographic breast density change was used as a surrogate marker for therapy response, results should be confirmed using clinically established outcomes measures.

News (Medical) associated with Endoxifen

13 May 2025

·www.prnewswire.com

Atossa Therapeutics Announces First Quarter 2025 Financial Results and Provides a Corporate Update

Announced strategic plan to advance (Z)-endoxifen for metastatic breast cancer indication Enhanced (Z)-endoxifen intellectual property portfolio with three new U.S. patents, expanding IP portfolio to more than 200 patent claims related to (Z)-endoxifen Ended first quarter 2025 with $65.1 million in cash and cash equivalents and no debt SEATTLE, May 13, 2025 /PRNewswire/ -- Atossa Therapeutics, Inc. (Nasdaq: ATOS) (Atossa or the Company), a clinical-stage biopharmaceutical company developing innovative medicines for breast cancer, today announced its financial results for the first quarter ended March 31, 2025 and provided an update on recent company developments. First Quarter 2025 Highlights: Announced Strategic Decision to Pursue Metastatic Breast Cancer Indication: Atossa announced plans to target metastatic breast cancer as its lead program for (Z)-endoxifen. The decision reflects its commitment to addressing the persistent unmet medical need in metastatic breast cancer and the potential for a more streamlined regulatory pathway to deliver (Z)-endoxifen to these patients. Current treatment options for metastatic breast cancer often provide limited durability of response and substantial side effects. In previous clinical trials, (Z)-endoxifen has been shown to be well-tolerated as a selective estrogen receptor modulator (SERM), which Atossa believes supports its potential to fill this critical gap in treatment. Significantly Strengthened (Z)-endoxifen Patent Portfolio with Three New U.S. Patents: Atossa continued to bolster the intellectual property portfolio of (Z)-endoxifen with the grant of three new U.S. patents covering 31 claims directed at: sustained release compositions of (Z)-endoxifen (U.S. Patent No. 12,201,591); enteric oral formulations of (Z)-endoxifen and salts thereof as well as their use in treating hormone-dependent breast and reproductive tract disorders (U.S. Patent No. 12,275,684); and 58 claims covering (Z)-endoxifen formulations, including various levels of purity and stability as well as methods of using those formulations (U.S. Patent No. 12,281,056). Atossa's robust patent portfolio now encompasses more than 200 patent claims related to (Z)-endoxifen formulations and their clinical applications. "Our focus remains firmly on advancing (Z)-endoxifen as a next-generation therapy for breast cancer patients across the full spectrum of care—including a strategic emphasis on metastatic breast cancer, where therapeutic innovation is urgently needed," said Steven Quay, M.D., Ph.D., President and Chief Executive Officer of Atossa. "Across multiple clinical trials involving hundreds of patients, (Z)-endoxifen has consistently demonstrated strong tolerability and therapeutic versatility, which we believe shows its potential as a therapy for breast cancer from early-stage disease to more advanced stages. We are committed to unlocking the full potential of (Z)-endoxifen for patients while delivering value to our shareholders. A cornerstone of this strategy is the robust intellectual property portfolio we are building in an effort to protect our programs globally. As we look ahead to the remainder of 2025 and beyond, we are energized by the many opportunities to position (Z)-endoxifen as a potentially safer, more effective endocrine therapy for breast cancer patients worldwide." Comparison of Three Months Ended March 31, 2025 and 2024 Revenue and Cost of Revenue. For the three months ended March 31, 2025 and 2024, we had no source of revenue and no associated cost of revenue. Operating Expenses. Total operating expenses were $7.4 million for the three months ended March 31, 2025, which was an increase of $0.4 million, from the three months ended March 31, 2024 of $7.0 million. Factors contributing to the increased operating expenses in the three months ended March 31, 2025 are explained below. Research & Development (R&D) Expenses. The following table provides a breakdown of major categories within R&D expenses for the three months ended March 31, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands): Clinical and pre-clinical trial expenses decreased $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024, due to a slight decrease in spend related to our (Z)-endoxifen trials, including drug development costs. The increase in R&D compensation expenses of $0.3 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 was due to an increase in headcount. The increase in R&D professional fees and other of $0.3 million was due to an increase in spending on regulatory consulting services. General and Administrative (G&A) Expenses. The following table provides a breakdown of major categories within G&A expenses for the three months ended March 31, 2025 and 2024, together with the dollar change and percentage change in those categories (dollars in thousands): The increase in G&A compensation expenses of $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024 was due to an increase in headcount quarter over quarter. Interest Income. Interest income was $0.7 million for the three months ended March 31, 2025, a decrease of $0.4 million from interest income of $1.1 million for the three months ended March 31, 2024. The decrease was due to a decrease in the balance in our money market account. About (Z)-Endoxifen (Z)-endoxifen is a highly potent SERM with demonstrated ability to inhibit—and potentially degrade—estrogen receptors. It has shown activity even in tumors that have developed resistance to other endocrine therapies. Beyond its anti-estrogenic properties, (Z)-endoxifen also targets protein kinase C beta 1 (PKCβ1), an oncogenic signaling protein, at clinically achievable blood levels. Importantly, (Z)-endoxifen seems to deliver comparable or superior bone-protective effects relative to tamoxifen, while exhibiting minimal or no endometrial proliferative activity—which we believe addresses key limitations of current standard-of-care therapies. Atossa is developing a proprietary oral formulation of (Z)-endoxifen that is enteric-coated to bypass stomach acid, which would otherwise convert the active (Z)-isomer to its inactive (E)-form. We believe this innovation allows for optimal bioavailability and therapeutic integrity. Clinical studies have shown Atossa's (Z)-endoxifen to be well tolerated in both healthy women and those with breast cancer. Atossa is prioritizing the development of (Z)-endoxifen for the treatment of metastatic breast cancer, where novel therapeutic options are urgently needed. The compound is currently being evaluated in three Phase 2 trials: one in women with ductal carcinoma in situ (DCIS) and two in women with estrogen receptor positive (ER+) / human epidermal growth factor receptor 2 negative (HER2-) breast cancer, including the EVANGELINE study and an I-SPY study. Atossa's (Z)-endoxifen program is supported by a growing global intellectual property portfolio, including three recently issued U.S. patents and numerous pending applications worldwide. About Atossa Therapeutics Atossa Therapeutics, Inc. (Nasdaq: ATOS) is a clinical-stage biopharmaceutical company dedicated to transforming breast cancer treatment through innovative science and patient-focused solutions. The company's lead product candidate, (Z)-endoxifen, is a highly potent SERM designed for use across the breast cancer spectrum, including prevention, neoadjuvant, adjuvant, and metastatic settings. Atossa is committed to advancing its robust clinical research programs to improve patient outcomes while creating sustainable value for shareholders. For more information, visit atossatherapeutics.com. FORWARD LOOKING STATEMENTS This press release contains certain information that may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. We may identify these forward-looking statements by the use of words such as "expect," "potential," "continue," "may," "will," "should," "could," "would," "seek," "intend," "plan," "estimate," "anticipate," "believe," "design," "predict," "future," or other comparable words. All statements made in this press release that are not statements of historical fact, including statements regarding data related to the (Z)-endoxifen program, the safety, tolerability and efficacy of (Z)-endoxifen, the potential of (Z)-endoxifen as a breast cancer prevention and treatment agent, the potential indications that the Company may pursue for (Z)-endoxifen, the potential for (Z)-endoxifen to receive regulatory approval, benefits of the Company's strategy of pursuing a metastatic indication for (Z)-endoxifen, the expected design and enrollment of trials and timing of data and related publications, and the potential market and growth opportunities for the Company, are forward-looking statements. Forward-looking statements in this press release are subject to risks and uncertainties that may cause actual results, outcomes, or the timing of actual results or outcomes, to differ materially from those projected or anticipated, including risks and uncertainties associated with: our ability to obtain patent coverage for our product candidates; macroeconomic conditions and increasing geopolitical instability; the expected timing of releasing data; any variation between interim or preliminary and final clinical results or analysis; actions and inactions by the FDA and foreign regulatory bodies; the outcome or timing of regulatory approvals needed by Atossa, including those needed to continue our planned (Z)-endoxifen trials; our ability to satisfy regulatory requirements; our ability to regain compliance or maintain compliance with the continued listing requirements of the Nasdaq Stock Market; our ability to successfully develop and commercialize new therapeutics; the success, costs and timing of our development activities, including our ability to successfully initiate or complete our clinical trials, including our (Z)-endoxifen trials; our anticipated rate of patient enrollment; our ability to contract with third-parties and their ability to perform adequately; our estimates on the size and characteristics of our potential markets; our ability to successfully defend litigation and other similar complaints and to establish and maintain intellectual property rights covering our products; whether we can successfully complete our clinical trial of oral (Z)-endoxifen in women with mammographic breast density and our trials of (Z)-endoxifen in women with breast cancer, and whether the studies will meet their objectives; our expectations as to future financial performance, expense levels and capital sources, including our ability to raise capital; our ability to attract and retain key personnel; our anticipated working capital needs and expectations around the sufficiency of our cash reserves; and other risks and uncertainties detailed from time to time in Atossa's filings with the Securities and Exchange Commission, including without limitation its Annual Reports on Form 10-K and Quarterly Reports on 10-Q. Forward-looking statements are presented as of the date of this press release. Except as required by law, we do not intend to update any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise. SOURCE Atossa Therapeutics Inc WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Financial StatementPhase 2

30 Apr 2024

·www.prnewswire.com

As Early-Onset Breast Cancer Cases Soar in North America and EU, Biotech Ramps Up Response

USA News Group Commentary VANCOUVER, BC, April 30, 2024 /PRNewswire/ -- USA News Group – An alarming rise in early-onset cancers has medical experts very concerned, as cancer cases in younger people are rising sharply. In particular, a surge in cases of breast cancer is being witnessed in Canada, the USA, and the EU, with extra concern to patients thought to be in remission contracting breast cancer a second time, according to a new study from the University of Cambridge. However, there's still optimism towards new treatments, and significant growth of 9.3% CAGR in the metastatic HR+/HER2- breast cancer market through 2032 has treatment developers working harder to make gains for patients. Among the biotech companies currently making strides are O ncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), IceCure Medical Ltd (NASDAQ: ICCM), Atossa Therapeutics, Inc. (NASDAQ: ATOS), Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE). Following a Fast Track Designation by the FDA in late 2022 for Oncolytics Biotech Inc.'s (NASDAQ: ONCY) (TSX: ONC) drug candidate, pelareorep, for pancreatic cancer treatment, the company is now gaining traction towards another pivotal FDA engagement, this time focusing on breast cancer. Recently, Oncolytics announced that they had submitted a Type C meeting request to the FDA to discuss a forthcoming trial for pelareorep aimed at treating HR+/HER2- metastatic breast cancer (mBC) patients. "A key focus for Oncolytics in 2024 is defining the regulatory path for pelareorep in breast cancer treatment," said Matt Coffey, President and CEO of Oncolytics. "We are optimistic that pelareorep, in combination with paclitaxel, could significantly enhance clinical outcomes for patients with HR+/HER2- metastatic breast cancer. Our position is strengthened by encouraging data from two randomized studies (BRACELET-1 and IND-213) and the AWARE-1 study, paving the way for the next phase of pelareorep's development and registration." Dr. Coffey has shared that Oncolytics' continuous interactions with clinical collaborators and partners have been instrumental in crafting a detailed and persuasive briefing document. The company looks forward to meeting with the FDA in Q2 2024 to finalize the trial design and goals for using pelareorep in treating metastatic breast cancer. This meeting is crucial for advancing this promising therapy toward patient use. With expected survival data from its BRACELET-1 study and constructive dialogues with the FDA, Oncolytics is optimistic that 2024 will be a landmark year for the company and its stakeholders. "The data from the randomized BRACELET-1 trial showcased compelling results for the pelareorep/paclitaxel combination therapy in HR+/HER2- metastatic breast cancer patients, with a nearly tripled confirmed response rate, a 50% improvement in median progression-free survival, and a hazard ratio of 0.29 compared to the paclitaxel alone control," said Thomas Heineman, M.D., Ph.D., Chief Medical Officer at Oncolytics. "Importantly, these data support the statistically significant near doubling of median overall survival in another randomized phase 2 study, IND-213, which also evaluated pelareorep and paclitaxel in HR+/HER2- metastatic breast cancer patients." Also seeking the FDA's attention, Israel-based IceCure Medical Ltd (NASDAQ: ICCM) recently reported its final ICE3 breast cancer cryoablation trial results with 100% patient and physician satisfaction and 96.3% recurrence-free rate for its ProSense® System, a minimally-invasive cryoablation technology that destroys tumors by freezing as an alternative to surgical tumor removal. With this new data in hand, IceCure has submitted final data to the FDA, requesting marketing authorization for ProSense® for the indication of treating patients with early-stage T1 invasive breast cancer with cryoablation and adjuvant hormone therapy. ProSense® has already received FDA Breakthrough Designation and is cleared for use in the US for several other indications, including treating benign tumors of the breast, and tumors in the kidney and liver. "We believe ICE3 is a ground-breaking study and are excited to report that the efficacy data of our minimally invasive ProSense® cryoablation procedure show similar outcomes in recurrence compared to more invasive breast surgery, the current standard of care for early-stage breast cancer," said Eyal Shamir, CEO of IceCure. "Initial reimbursement codes are already in place and our U.S. marketing and commercial team is ready, as we await the FDA's response. Driven by favorable healthcare economics combined with patient satisfaction and demand, we expect rapid adoption pending FDA granting the DeNovo Classification Request for Marketing Approval." A new clinical trial was announced by Atossa Therapeutics, Inc. (NASDAQ: ATOS) to evaluate the company's proprietary (Z)-endoxifen in combination with abemaciclib (VERZENIO®), a cyclin-dependent kinase (CDK) 4/6 inhibitor marketed by Eli Lilly and Company, in women with ER+/HER2- breast cancer. Set to enroll approximately 20 newly diagnosed women, the new study arm will have participants receiving 40mg (Z)-endoxifen once daily in combination with 150mg abemaciclib twice daily for a total of 24 weeks prior to surgery. "Endocrine therapy in combination with CDK 4/6 inhibition is a widely used treatment for patients with advanced-stage ER+ breast cancer and as an adjuvant therapy for node positive, hormone positive early-stage disease, found at the time of surgical resection," said Dr. Laura Esserman, director of the University of California San Francisco Breast Care Center and founder of Quantum Leap Healthcare Collaborative. "Women with high clinical stage but less proliferative tumors (molecularly low risk or those with late recurrence risk) are challenging to treat. Late recurrence is high regardless of either endocrine or chemotherapy. Thus, we are looking for new combined treatments, which can be used in the pre-surgery (neoadjuvant) setting. We look forward to learning more about the potential of (Z)-endoxifen in combination with abemaciclib in the neoadjuvant setting in the I-SPY TRIAL." Vepdegestrant (ARV-471) is another treatment that recently received FDA Fast Track Designation, which is a novel oral PROteolysis Targeting Chimera (PROTAC®) ER degrader that is being jointly developed by Arvinas, Inc. (NASDAQ: ARVN), and Pfizer Inc. (NYSE: PFE) (NEO: PFE). The ongoing Phase 3 VERITAC-2 clinical trial is evaluating vepdegestrant or fulvestrant in patients with locally advanced or metastatic ER+/HER2- breast cancer who have been previously treated with an endocrine-based therapy. "The receipt of Fast Track designation reinforces the potential of vepdegestrant to provide an important new therapeutic option for people with ER+/HER2- breast cancer whose disease has progressed," said Roger Dansey, M.D., Chief Development Officer, Oncology, Pfizer. "We are proud to continue our legacy of developing innovative treatment options for people impacted by metastatic breast cancer and look forward to working with the FDA as we advance our development program for vepdegestrant." Article Source: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. SOURCE USA News Group

Fast TrackPhase 2Clinical ResultBreakthrough Therapy

26 Jan 2024

·www.pharmaceutical-technology.com

Atossa Therapeutics progresses Phase II preventative breast cancer therapy

Atossa Therapeutics’ CEO discussed updates for its breast cancer program. Credit: NDAB Creativity via Shutterstock Atossa Therapeutics estimates a Q3 readout of a Phase II trial that studies the company’s lead asset z-endoxifen, says CEO Dr. Steven Quay, in an interview with Pharmaceutical Technology . In December, the US-based biotech announced that it had completed enrollment for its Karisma endoxifen Phase II trial (NCT05068388), reaching 80% of its initial goal. Atossa is conducting the study at the South General Hospital in Stockholm, recruiting 240 pre-menopausal women with measurable MBD. Quay said that the company estimates a Phase II data readout for the trial in Q3 2024. The Karisma study is investigatings Z-endoxifen as a preventative treatment for breast cancer. Quay mentions that the US Food and Drug Administration (FDA) typically does not approve preventative therapies for cancer as many patients pass away during the trial. Furthermore, he highlights the uncertainty surrounding the ideal trial length for preventative studies and choosing the necessary endpoints. The company plans to discuss Phase III plans with the FDA to devise an appropriate trial design. Atossa is also investigating the drug in the I-Spy 2 trial (NCT01042379) and the EVANGELINE trial (NCT05607004) for the treatment of ER+ invasive breast cancer in pre-and postmenopausal women and grade 1 or 2 ER+/HER2 breast cancer in premenopausal women respectively. Z-endoxifen acts by binding to oestrogen receptors, causing a blockage of the oestrogen-dependent gene. The therapy has a patented oral enteric capsule formulation that stabilises it upon oral administration. In 2024, the company plans to present data from its ongoing trials at multiple conferences, says Quay. This includes the American Association for Cancer Research (AACR) annual meeting in April, and the American Society of Clinical Oncology (ASCO) annual meeting in June, says Quay. In a 9 January letter to investors, Quay declared that the company had “a strong balance sheet with no debt and cash, cash equivalents and restricted cash of $94 million as of September 30, 2023.” The company achieved this through the June 2023 launch of a share repurchase program, which allowed them to raise $1.475 million in 2023, amongst other things. The company has extended this share repurchase program through to 31 December 2024. The program permits the purchase of up to $10 million of Atossa’s common stock, including purchases made in 2023. Quay says the company is also open to partnerships to potentially test its drug in a combination therapy setting . He says that once Phase II data has released, the company may leverage it to begin partnership discussions.

Phase 2ASCO

100 Deals associated with Endoxifen

R&D Status

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Mania	Phase 3	United States	Jina Pharmaceuticals, Inc.	19 Mar 2024
Bipolar I disorder	Phase 3	United States	Jina Pharmaceuticals, Inc.	03 Aug 2020
ER-positive/HER2-negative Breast Cancer	Phase 2	United States	Inclin, Inc.	14 Feb 2023
ER-positive/HER2-negative Breast Cancer	Phase 2	United States	Atossa Therapeutics, Inc.	14 Feb 2023
Estrogen receptor positive breast cancer	Phase 2	United States	Atossa Therapeutics, Inc.	14 Feb 2023
Estrogen receptor positive breast cancer	Phase 2	United States	Inclin, Inc.	14 Feb 2023
HER2-negative breast cancer	Phase 2	United States	Inclin, Inc.	14 Feb 2023
HER2-negative breast cancer	Phase 2	United States	Atossa Therapeutics, Inc.	14 Feb 2023
Invasive Mammary Carcinoma	Phase 2	United States	Inclin, Inc.	14 Feb 2023
Invasive Mammary Carcinoma	Phase 2	United States	Atossa Therapeutics, Inc.	14 Feb 2023

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


AACR2025	Not Applicable	ESR1 mutations (Y537S, D538G)	-	(Z)-Endoxifen (ENDX)	owoquliwkx(obyebivyeh) = nhnfbpyhau nsmlbkjasd (qxvyhobxbk )	-	29 Apr 2025
				AT416E	owoquliwkx(obyebivyeh) = qwziytjkwe nsmlbkjasd (qxvyhobxbk )
NCT05068388 (KARISMA-Endoxifen, Company_Website) Manual	Phase 2	Breast Cancer	-	(Z)-endoxifen 1 mg	snxikqjxfd(ttwryyfmbr) = gmtrtbaboo cbxoqobcnn (lecbwgzpxt ) View more	Positive	04 Nov 2024
				(Z)-endoxifen 2 mg	snxikqjxfd(ttwryyfmbr) = rivvcezxec cbxoqobcnn (lecbwgzpxt ) View more
NCT05607004 (EVANGELINE, AACR2024) Manual	Phase 2	Premenopausal breast cancer Neoadjuvant HER2 Negative \| Proliferation marker protein Ki-67 \| ER Positive	7	(Z)-endoxifen 40 mg/day	utxrptljnk(lqwmjrhfgx) = dhtljngrlk aizsfejzqz (ujdezfprfm, 180.3 - 376.6) View more	Positive	05 Apr 2024
NCT03317405 (CTgov)	Phase 1	Breast Ductal Carcinoma \| Breast Carcinoma in Situ \| Breast Cancer 3	32	Endoxifen Hydrochloride (Endoxifen Hydrochloride Gel 10 mg Daily)	evaoklqvml = wpbhbwuhew ansljlepbc (tirluqturn, ccrdscjahi - zappwvbvur) View more	-	13 Jun 2023
				Endoxifen Hydrochloride (Endoxifen Hydrochloride Gel 20 mg Daily)	evaoklqvml = khajuwchph ansljlepbc (tirluqturn, ukbqduceuf - rpltwgtpge) View more
NCT04616430 (CREME, CTgov)	Phase 2	Breast Diseases	90	Placebo (Control)	tgvozccxez(lnkjkuuegy) = jcuvlhgmhw qgxwvkfmes (hjbnpygfjp, 5.58) View more	-	18 Jun 2021
				Topical endoxifen (Topical Endoxifen 10mg/Breast/Day)	tgvozccxez(lnkjkuuegy) = waiafzbcqt qgxwvkfmes (hjbnpygfjp, 6.50) View more
NCT02311933 (AACR2020) Manual	Phase 2	HER2-negative breast cancer \| Estrogen receptor positive breast cancer HER2 negative \| ER Positive	77	Z-endoxifen HCL	dnjbhfnpfn(oxrasfuggq) = uldrwxljpr krkzngpako (dxqlzicqrt, 76 - 138)	Non-superior	15 Feb 2020
				tamoxifen	dnjbhfnpfn(oxrasfuggq) = ogymgwmiqg krkzngpako (dxqlzicqrt, 24 - 129)
NCT01273168 (ASCO 12018 \| ASCO 22018) Manual	Phase 1	HR positive solid tumors HR Positive	40	Endoxifen	fxftrmkyrm(jgubghiwsf) = hypertension (13%), hyponatremia (8%), hypophosphatemia (8%), neutropenia (8%), dehydration (5%), and elevated ALT (5%) vrydqmdkbl (abrerjrceo ) View more	Positive	04 Jun 2018
NCT01327781 (MC093C, ASCO2017)	Phase 1	Hormone refractory breast cancer	41	Z-endoxifen	aflsngdnwc(hhzypsrgxy) = txmlrrjzkd yichoewwpm (byasggkrnk, 13.4 - 43.1) View more	-	30 May 2017
P1-08-03 (SABCS2017)	Not Applicable	-	-	Tamoxifen	ydmeqvliwu(cjulbmqusv) = kilvcxnfvg tdveswsaqv (kslmaaxvyq )	-	15 Feb 2017
				Endoxifen	ydmeqvliwu(cjulbmqusv) = ijjowmmlgs tdveswsaqv (kslmaaxvyq )
NCT01327781 (phase I study of Z-Endoxifen hydrochloride, SABCS2016)	Phase 1	Metastatic breast cancer ER+	41	Z-Endoxifen hydrochloride (Z-Endx)	lzwoexyrgq(koxdndvwmh) = wqigwhraxz fipycclecm (ketkgdwshq )	Positive	15 Feb 2016

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